To assess the safety of copanlisib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
60 mg of experimental drug in solution administered intravenously on Days 1, 8 and 15 of each 28-day treatment cycle
Unnamed facility
Jaú, São Paulo, Brazil
Unnamed facility
São Paulo, São Paulo, Brazil
Unnamed facility
São Paulo, Brazil
Number of Participants With Treatment-emergent Adverse Events (TEAE)s
Adverse event data were collected after signing the informed consent until 30 days after the last study drug administration (end of safety follow-up)
Time frame: up to 7 years
Number of Participants With Treatment-emergent Serious Adverse Events (TESAE)s
Serious adverse event data were collected after signing the informed consent until 30 days after the last study drug administration (end of safety follow-up)
Time frame: up to 7 years
Number of Participants With Abnormal Laboratory Parameters
\- Above threshold of 10% and reported as TEAEs - any event (Grade 1-4)
Time frame: up to 7 years
Number of Participants With Abnormal Vital Signs
\- Reported as TEAEs - worst CTCAE grade total -
Time frame: up to 7 years
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Unnamed facility
Plovdiv, Bulgaria
Unnamed facility
Athens, Greece
Unnamed facility
Bologna, Emilia-Romagna, Italy
Unnamed facility
Genoa, Liguria, Italy
Unnamed facility
Gdynia, Poland
Unnamed facility
Kazan', Russia
Unnamed facility
Kemerovo, Russia
...and 11 more locations